Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Dec 10, 2025
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microbiologics Inc.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Paragon 28, Inc.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
IntelliVue MP2. Product Number: M8102A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
23 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 10, 2025
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, LLC
FDA (openFDA device enforcement)
Reported Dec 10, 2025
MAMMOMAT Revelation;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Argon Medical Devices, Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.B Braun Medical Inc.
115 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cepheid
FDA (openFDA device enforcement)
Reported Dec 3, 2025
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Dermasensor Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Djo, LLC
FDA (openFDA device enforcement)
Reported Dec 3, 2025
FoundationOne CDx (F1CDx), RAL-0003 version 31.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Foundation Medicine, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Glycar SA Pty., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
FlexLab (FLX); Version: FLX-217-10;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inpeco S.A.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
IntelePACS - InteleConnect / TechPortal
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intelerad Medical Systems Incorporated
FDA (openFDA device enforcement)
Reported Dec 3, 2025
The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Magellan Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
CareLink Clinic, REF: MMT-7350
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mindray DS USA, Inc. dba Mindray North America
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Noah Medical Corporation
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Medical Systems Nederland B.v.
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.